In a pivotal move, the US Food and Drug Administration said Monday that it is taking steps to remove the lengthy “black box” warning on many hormone treatments for women with menopause symptoms, a shift expected to give women more options for treatment and generate a flood of new prescriptions.

Hormone therapy has long been on the market, but prescriptions plummeted after 2003, when the warning described increased risks of cardiovascular disease, stroke, breast cancer and dementia.

“After 23 years of dogma, the FDA today is announcing that we are going to stop the fear machine steering women away from this life-changing, even life-saving, treatment,” FDA Commissioner Dr. Marty Makary said in announcing the change.

Prescribing requires nuance, FDA officials said, especially around when women start hormone therapy. Some women still face some risks from hormone therapy, including those at increased risk of blood clots or who have previously had breast cancer.

But for many women, the benefits may far outweigh the risks.

“With the exception of vaccines or antibiotics, there’s no medication that can improve the health of women on a population level more than hormone replacement therapy,” Makary posted on X Monday morning.

It could take months for the labels to change, but drugmakers are “very excited” to make the update, Makary said.